FDA 510(k)

REAL Immersive System

K号: K183296 · 2019-03-18

决定日期2019-03-18

产品代码ISD

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决定实质等同

器械摘要

REAL Immersive System is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2019-03-18 under 510(k) number K183296. The device is classified under product code ISD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the REAL Immersive System?

REAL Immersive System is a medical device that received FDA 510(k) clearance on 2019-03-18. The listed applicant is Penumbra, Inc.. The 510(k) number is K183296.

When did REAL Immersive System receive FDA 510(k) clearance?

REAL Immersive System received FDA 510(k) clearance on 2019-03-18, under 510(k) number K183296.

Who is the listed applicant for REAL Immersive System?

The FDA 510(k) record lists Penumbra, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REAL Immersive System?

The FDA product code for REAL Immersive System is ISD.

列明Penumbra, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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